The following data is part of a premarket notification filed by Bayer Healthcare Llc with the FDA for Advia Chemistry Microalbumin Controls.
| Device ID | K052242 |
| 510k Number | K052242 |
| Device Name: | ADVIA CHEMISTRY MICROALBUMIN CONTROLS |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | BAYER HEALTHCARE LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Andres Holle |
| Correspondent | Andres Holle BAYER HEALTHCARE LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-17 |
| Decision Date | 2005-10-03 |
| Summary: | summary |